Good morning, Mr. Chairman. I am Dr. Keiji Fukuda from the Centers for Disease Control and
Prevention (CDC). I'm happy to be here today to provide information regarding last year's
influenza vaccine delays and efforts underway to help mitigate similar potential problems in the
future.

Introduction

Influenza vaccine is the best tool to prevent severe illness and death related to influenza among
the elderly and chronically ill in the United States. As the Nation's prevention agency, CDC's
overriding public health concern is to prevent hospitalizations and deaths, especially among high
risk persons. Influenza causes, on average, approximately 20,000 excess deaths and
approximately 110,000 hospitalizations per year. For each 1 million persons over the age of 65
vaccinated in an average influenza season approximately 900 deaths and 1,300 hospitalizations
are prevented.

The 2000-2001 vaccine delay was severe and unusual. In other seasons, the system for providing
and distributing influenza vaccine has successfully met vast flu vaccine needs and in recent years
has provided between 70-80 million vaccine doses annually.

Influenza vaccine is produced and primarily distributed in the private sector. CDC vaccine
recommendations are made through a deliberative process involving advice and guidance from
the Advisory Committee on Immunization Practices (ACIP). Although CDC's ACIP issues
recommendations regarding influenza vaccination, including which groups of individuals are at
highest risk for developing complications from influenza and optimal time frames for
administering vaccine, influenza vaccine production is solely in the private sector, and the
distribution of the vaccine is primarily through the private sector. Because of this, if vaccine
manufacturers have delayed production or a shortage of flu vaccine, CDC can take steps to
minimize the effects, but cannot solve the entire problem.

Flu Vaccine Production in 2000-2001

Each year, manufacturers produce a new influenza vaccine, based upon the selection of viral
strains that are most likely to circulate for the upcoming influenza season. This is done to
produce the most effective vaccine possible each year. A relatively short window exists between
the time when viral strains are selected and when manufacturers develop and produce vaccine for
each season. Delays can occur due to difficulties in growing or processing the vaccine strains or
due to other manufacturing issues, and these delays in turn can affect vaccine distribution.

By June 2000, it became clear from discussions between influenza vaccine manufacturers and
federal public health officials that there was a possibility of delays or shortages in influenza
vaccine shipments for the 2000-2001 influenza season. This potential delay and possibility of a
shortage was due to a combination of factors including difficulty by some manufacturers in
growing and processing one of the virus strains used in vaccine and good manufacturing practice
issues with two companies. Ultimately, a significant delay in the availability of influenza
vaccine occurred, resulting in concerns regarding the distribution and pricing system of influenza
vaccine. One of the four manufacturers withdrew from the market and did not distribute any
vaccine.

CDC Actions

To deal with the delays and potential shortfall, CDC undertook a number of activities. CDC
contracted with one manufacturer to extend their production period and produce up to 9 million
additional doses of additional influenza vaccine. This decision was made to protect the nation
against severe shortage. The additional vaccine was available in December 2000 and as a result,
the final supply of influenza vaccine approximated what was distributed in the previous year;
however, a substantial amount of vaccine reached providers much later than usual creating
functional shortages for some providers. In addition to CDC's contracting for the production of
additional influenza vaccine, CDC: 1) recommended that vaccine be administered to high-risk
individuals first, 2) provided an internet-based system to facilitate the exchange and
redistribution of vaccine, 3) conducted promotional campaigns to encourage vaccination of high
risk persons, 4) communicated with health care providers and partners to keep them informed of
events, and 5) encouraged states to develop plans to help manage and direct vaccine supplies in
their jurisdictions.

CDC's influenza education and media campaign encouraged people at high risk of complications
from influenza to seek a flu shot and to encourage healthy people 50-64 to seek flu shots in
December and early January. The campaign was based on discussions with a total of 26 focus
groups that were held around the country with African Americans, Spanish-speaking Hispanics
and Caucasians. The groups were used to determine and test key messages. Both English-language and Spanish-language versions of the campaign materials were made available,
including television, radio public service announcements, and one-page flyers.

These initiatives were undertaken to help mitigate the effect of vaccine delays. But, as
previously indicated, influenza vaccine is produced in the private sector and is also largely
distributed there. The Federal government does not control the private production and
distribution system. Therefore, despite our best efforts, some patients (including those at high
risk) and providers experienced delays in obtaining vaccine, resulting in uneven distribution.
The degree of delay experienced by individual providers varied greatly, depending on the
vaccine manufacturer, distributor, and when vaccine was ordered.

The GAO Report entitled, "Flu Vaccine: Supply Problems Heighten Need to Ensure Access for
High-Risk People," looked at these issues. In general, CDC agrees with the GAO report and
continues to take a leadership role in supporting efforts to address influenza vaccination. As
GAO acknowledges, the purchase, distribution, and administration of influenza vaccine are
mainly private-sector responsibilities. Substantial efforts have been made by the Department to
address future influenza immunization concerns. CDC is working proactively with the Food and
Drug Administration, manufacturers, distributors, State and local health departments and other
key partners to better prepare for the upcoming flu season.

The Upcoming Flu Season: What We Expect

Three manufacturers are currently producing influenza vaccine for the U.S. population. Each has
provided an estimate of vaccine production for the upcoming year. Based upon the
manufacturers' estimates, the total possible vaccine available in the 2001-2002 influenza season
may be up to 84 million doses. In a usual year, approximately 70-80 million doses of vaccine are
distributed. However, it's important to note that the manufacturers' estimates are subject to
change, and it is not possible to know for certain how much vaccine may be available, or when it
may be available, until much later this year.

Because influenza vaccine is newly produced for each influenza season, numerous factors may
affect the manufacturers' vaccine production and distribution. If some manufacturers are delayed
in getting their vaccine to the providers, there will be uneven distribution of the vaccine with
providers who ordered from some manufacturers receiving vaccine later than providers who
ordered from other manufacturers. Further, providers who order late may receive vaccine late.
Providers who order from third party distributors will be dependent upon which manufacturer is
supplying that distributor.

CDC Plans

CDC has been working with the private sector, state and local health officials and provider
organizations in the development of contingency plans and is taking steps to help assure high-risk patients are vaccinated in the event of a delay or shortage. Several activities are underway
and planned to anticipate and deal with potential problems.

1) CDC and the American Medical Association hosted a meeting on March 27, 2001 with
manufacturers, selected distributors, trade organizations, provider organizations and public health
officials to discuss the need for contingency plans and to learn more about the private sector
production and distribution challenges.

2) CDC has requested that states develop contingency plans in the event of an influenza vaccine
shortage and has provided written guidelines to assist them in planning. CDC requested that
states submit their draft contingency plans by June 2001. CDC will hold a workshop at the
National Immunization Conference this week to share planning efforts and best practices so that
plans can be finalized by August of this year. CDC will also share state plans as they become
available.

3) CDC also plans to send letters to health care provider organizations serving high-risk
populations, including nursing homes, specialty physicians, and will work with Health Care
Financing Adminstration (HCFA) to notify providers who participate in Medicare
reimbursement plans, reminding them to order vaccine now and to immunize high-risk
individuals at the earliest possible time.

4) One manufacturer has indicated it plans to fill approximately 25% of each customer's order in
September. If, after that, a vaccine shortage or delay is expected, they will work with CDC to
reallocate some amount of their remaining vaccine to their customers who serve high-risk
patients, as well as to the high-risk customers of any non-producing manufacturer.

5) The ACIP influenza recommendations were revised this year to extend the optimal
vaccination period for high-risk individuals to the end of November (see Appendix I). Health
care providers should continue to offer vaccine to unvaccinated persons after November and
throughout the influenza season even after influenza has been documented in the community.
Influenza activity peaked during January in 5 of the last 19 years and in February or later in 10 of
the last 19 years. Therefore, immunizations should continue even after November because they
can still confer significant benefit in the great majority of influenza seasons. ACIP
recommendations also suggest that persons planning substantial organized vaccination
campaigns consider scheduling these events after mid-October, to minimize cancellations if
vaccine delivery is delayed.

The new ACIP recommendations also encourage physicians to strongly consider administering
pneumococcal and influenza vaccines at the same time to persons who had not previously
received the pneumococcal vaccine. The target groups for these vaccines overlap considerably,
and disease caused by pneumococcus and other types of bacteria can be a major complication of
influenza. Pneumococcal vaccination has some value in protecting against complications of
influenza, but is not a substitute for flu vaccine for several reasons: 1) pneumococcal vaccine
does not protect against influenza, 2) many influenza complications resulting in hospitalization
are not related to pneumococcal disease, and 3) the pneumococcal vaccine may only protect
against the 10 to 25 percent of cases of pneumococcal bloodstream infections (bacteremia).

For the long-term, it is important to increase collaboration between State and local health
officials and private sector vaccine distributors and providers on a routine basis. These
collaborative relationships would be critical in redirecting vaccine, if necessary, during a
shortage or delay in availability.

Conclusion

Mr. Chairman, it was an unusual year for flu vaccination. There were problems throughout the
country caused by the supply and distribution of vaccine. CDC, and its partners, took steps to
make the situation better and minimize the effects of the delays. Fortunately, the 2000-2001
season was unusually mild, which probably diminished demand for the influenza vaccine. We
must anticipate that future seasons may be more severe, emphasizing the need to establish long-term solutions. CDC and its public and private sector partners will continue to work closely
together to target vaccination to high risk individuals first to minimize the adverse impact of
delays. As the season progresses and more information is available regarding influenza vaccine
supply, CDC will provide updates at its website at www.cdc.gov.

Thank you again for your interest in this important public health issue. I would be happy to
respond to any questions you may have.

Appendix I

CDC has published the Advisory Committee on Immunization Practices' (ACIP)
recommendations, "Prevention and Control of Influenza" in the April 20, 2001 Morbidity and
Mortality Weekly Report. (The MMWR can be found at www.cdc.gov).

The ACIP recommends vaccination for the following people who are at high risk for
complications from influenza:

persons aged > 65 years;

residents of nursing homes and other chronic-care
facilities that house persons of any age who have chronic
medical conditions;

adults and children who have chronic disorders
of the pulmonary or cardiovascular systems, including
asthma;

adults and children who have required medical
follow-up or hospitalization during the preceding year
because of chronic metabolic diseases (including diabetes
mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression
(including immunosuppresion caused by medications or by
human immunodeficiency virus);

children and teenagers (aged 6 months to 18
years) who are receiving long-term aspirin therapy and,
therefore, might be at risk for developing Reye syndrome
after influenza infection; and

women who will be in the second or third trimester
of pregnancy during the influenza season.

In addition to these groups of individuals at high risk of complications from influenza,
vaccination is also recommended for all persons aged 50 - 64 years because the prevalence of
individuals with high-risk conditions in this age group is elevated, and for health-care workers
and others in close contact with persons at high risk, including household members because they
can easily pass infection onto high risk persons.